F.D.A. Commissioner Leaving After Six Years of Breakneck Changes

Dr. Margaret Hamburg is stepping down from the Food and Drug Administration.Credit
Shannon Stapleton/Reuters

Dr. Margaret Hamburg, the commissioner of the Food and Drug Administration, who led the agency for nearly six years through a period of rapid change in medical science, announced Thursday that she was stepping down.

Dr. Hamburg, 59, told colleagues in an email that she would depart at the end of March. She said in a telephone interview that she had never expected to stay as long as she did but had kept finding issues she wanted to shape and problems she wanted to help solve. She said she was particularly proud of her role in modernizing how the agency regulated the safety of food and drugs coming from other countries.

“Six years in this job is really a lot,” she said. “When I took over, it was often described as an agency in crisis. I’ve been able to turn that around, to really improve morale and change the culture of the agency in some important ways. I hope that I’ve really made it a stronger and better place.”

One of the longest-serving commissioners at the agency, Dr. Hamburg was nominated by President Obama and confirmed by the Senate in 2009. She had a behind-the-scenes leadership style that some criticized as not tough enough but others praised as the best way to be effective in an era of intensely partisan politics.

The F.D.A. is a big agency. Its officials like to say that it regulates about 20 cents on every dollar spent by American consumers, and its authority extends from drugs and food to medical devices and tobacco. Dr. Hamburg has grappled with some of the biggest public health issues of the day: the opioid painkiller abuse epidemic, obesity and the rise of electronic cigarettes. She has said that the agency is making strides in an era that has brought a burst of new individualized treatments for small populations of patients based on genes.

“In virtually every issue that arises, she grasps it quickly and deeply and asks questions that force people to see a different dimension of it,” said Dr. Thomas R. Frieden, the director of the Centers for Disease Control and Prevention.

Under Dr. Hamburg, the pace at which the agency approved drugs quickened, prompting praise from an industry that had chafed at a more cautious approval process in the wake of the regulatory scandal over Vioxx, an arthritis drug that was believed to have caused thousands of cardiac deaths before being pulled from the market in 2004.

In a blog post earlier this week, Dr. Hamburg said the F.D.A. had approved 51 drugs in 2014, the most in almost 20 years. She called that a testament to its “innovative approaches to help expedite development and review of medical products that target unmet medical needs.”

While some have criticized the agency for speeding approvals too much at the expense of safety, others said the pace was justified.

Nancy Goodman, the executive director of Kids v Cancer, a nonprofit advocacy group, praised Dr. Hamburg in an email. Ms. Goodman, who lost a son to cancer, said she was grateful for the pace of pediatric cancer drug development, “including simpler, faster and cheaper trials and the implementation of the Creating Hope Act pediatric rare-disease priority review program.” The act is intended to provide market incentives to pharmaceutical companies to develop new drugs for children with rare pediatric diseases.

Some public interest groups were critical. Dr. Michael Carome, the director of the health research group at Public Citizen, based in Washington, called her tenure a period “of weak and ineffective leadership.”

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”Too often, the F.D.A. has succumbed to industry and political pressures, implementing policies and taking actions that tilt too far toward the bottom-line interests of pharmaceutical and medical-device companies, and away from protecting public health,” he said in a statement.

But many experts took issue with that assertion, saying Dr. Hamburg could take a tough line with industry, though such stances were not obvious to the public.

A low point in her tenure came in the fall of 2012, when a pharmacy based in Massachusetts produced tainted epidural steroids that killed 64 people and sickened hundreds of others across the country with fungal meningitis.

She was grilled by lawmakers, who said she had not fulfilled her duties as leader of the nation’s top drug regulatory agency. But other experts contended that the agency had limited legal power under the law — such pharmacies, known as compounders, were regulated by states, not the federal government — and that an accident had been bound to happen because of the murky legal framework. Congress later passed legislation clarifying the agency’s role.

Another tough moment for Dr. Hamburg was when she weighed in on a controversy around the so-called morning-after pill. Kathleen Sebelius, who was the secretary of the Department of Health and Human Services, overruled the F.D.A.’s 2011 decision to allow the most common morning-after pill to be sold over the counter to all ages. Dr. Hamburg stood up for the agency’s decision, under substantial pressure, and was eventually vindicated by a federal judge’s ruling that overturned the Health and Human Services decision.

Daniel Carpenter, a Harvard University political scientist who studies the F.D.A., noted the drug-safety problems that plagued the agency in the years before Dr. Hamburg took over. “She led the agency out of crisis,” he said. “She got the funding. There’s a steadiness there, a sense that the agency is growing.”

Asked whether she had been pushed out of the job, Dr. Hamburg laughed and said that she had spoken to the current secretary of the Department of Health and Human Services, Sylvia Mathews Burwell, about the transition last week.

“She said, ‘You know, we really want you to stay; it’s not too late if you want to change your mind,’” Dr. Hamburg recalled. “I said it’s been a really hard decision, and it has been.”

Dr. Hamburg added, “I’m leaving because I feel like it is time.”

She was New York City’s health commissioner in the 1990s, when tuberculosis had become increasingly resistant to standard drugs. She sent health care workers to patients’ homes to help them manage their drug regimens. New York City increased cure rates and reduced tuberculosis significantly.

She comes from a family of prominent doctors. Her father was a renowned psychiatrist, and her mother was the first black woman to attend Vassar College and to graduate from the Yale University School of Medicine. Dr. Hamburg was the first New York City health commissioner to give birth while in office, and her children’s birth certificates bear her name in two places: as their mother and as health commissioner.

A version of this article appears in print on February 6, 2015, on Page A12 of the New York edition with the headline: F.D.A. Commissioner Leaving After Six Years of Breakneck Changes. Order Reprints|Today's Paper|Subscribe